This year has produced many developments in the ongoing battle between the FDA and e-cigarette manufacturer Juul Labs, Inc. Most notably, on June 23, 2022, the FDA ordered the removal of Juul’s vaping devices and pods from the market due to insufficient evidence regarding the safety of the company’s products. The market denial ordered the immediate removal and distribution of Juul products in the United States. Juul quickly received a temporary stay on the ban and is now taking the FDA to court over the market denial order.
FDA Issues Market Denial Order for Juul Products
On June 23, 2022, the FDA denied Juul authorization to market any of its products in the United States. After the agency reviewed Juul’s premarket tobacco product applications, it determined Juul’s submission lacked evidence for the toxicological effects of its products. Without the toxicological profile, the FDA did not have enough data to approve the marketing out of protection for public health. While the FDA admitted that it did not have clinical information to suggest that Juul products posed an immediate hazard, it does not have the evidence required to absolve Juul products of any risks to consumers.
Just one day after the FDA’s announcement, Juul filed an emergency motion with the U.S. Court of Appeals for the D.C. Circuit to temporarily stay the ban. The court of appeals approved Juul’s motion and granted a temporary stay until July 12, 2022. However, before this date, the FDA administratively stayed the marketing denial order on July 5, 2022. The FDA stated that it needed additional time to review the scientific issues surrounding Juul products.
Juul Files Lawsuit After FDA Rejects Company’s Request for Information
Less than a day after the FDA implemented its marketing denial order for Juul products, the company requested documents and disciplinary reviews through the Freedom of Information Act. This act bestows the public the right to request access to records from any federal agency. In response to Juul’s request, the FDA provided only a portion of the applicable documents by invoking the “deliberative process privilege.”
The deliberative process privilege is one of the few avenues federal agencies can take in order to justify withholding documents. In the lawsuit filed on September 20, Juul mentioned the FDA agreed to release only 115 pages of the 292 requested by Juul. The company filed an administrative appeal, but the FDA did not respond by the September 13 deadline, which prompted Juul to file the lawsuit. Juul argues that without these documents, the company cannot begin to understand the reasons for the FDA’s market denial order and what the agency’s scientific review discovered that would have resulted in the ban.